Medicine

Statin Exposure and Risk of Dialysis in Type 2 Diabetes: A Real-World Cohort Study

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This retrospective cohort study of 32,125 adults with type 2 diabetes examined whether statin use is associated with the time to dialysis initiation. Using time-varying exposure models and competing-risk analyses, the study found that while current statin exposure showed a marginally higher crude hazard of dialysis (HR 1.043), new users who initiated statins at least 90 days before follow-up demonstrated a significantly reduced risk of dialysis (HR 0.73, 95% CI 0.57-0.92). These contrasting results suggest that the timing of statin initiation and immortal time bias are critical factors when interpreting the renal effects of statins in diabetic populations.


If confirmed in peer-reviewed and prospective studies, early statin initiation in type 2 diabetes patients may represent a modifiable factor in delaying or reducing the need for renal replacement therapy, which carries substantial clinical and economic burden. Clinicians managing diabetic nephropathy progression could potentially use these findings to inform the timing of statin prescriptions.


⚠️ Preprint – Noch nicht peer-reviewed

Dieser Artikel wurde noch nicht von unabhängigen Experten begutachtet. Die Ergebnisse sind vorläufig und sollten mit Vorsicht interpretiert werden.

Background: Renal effects of statins in type 2 diabetes mellitus (T2DM) remain uncertain. We evaluated whether statin exposure is associated with time to dialysis initiation. Methods: We conducted a retrospective cohort study of adults with T2DM, indexing follow-up at diagnosis during first hospital admission (day 0) between january 2017 and march 2025. Statin use was modeled as time-varying from statin days; (classified in 3 categories: baseline users, new users, and never users). The primary outcome was dialysis. Analysis estimated cause-specific hazards, censoring deaths; proportional hazards were checked with prespecified windows of statin exposure (0?1, 1?3, > 3 years). Competing-risk analyses (Fine?Gray) assessed the sub-distribution hazard of dialysis with death as a competing event in two models: (i) prevalent users at baseline and (ii) new-users with post-initiation intervals of 30 and 90 days. An Observational Medical Outcomes Partnership Common Data Model standardized dataset of a Brazilian quaternary hospital, and the Real-World Data tool MD Clone were used in the study. Results: Of 36,246 adults identified, 32,125 entered the time-varying cohort (39,943 risk intervals; 656 dialysis events); median follow-up among censored patients was 753 days. At baseline, 70.3% never used statins, 5.5% were users (? 0 days), and 24.2% initiated after diagnosis. Crude dialysis incidence was 4.51 vs. 12.31 per 1,000 patient-years during unexposed vs. exposed time. In the adjusted time-varying Cox model, current statin exposure was associated with a modestly higher hazard of dialysis (HR = 1.043, 95% CI 1.011?1.077). In the new-users analysis, HRs were 0.83 (95% CI 0.66?1.05), and 0.73 (95% CI 0.57?0.92) with a 30-day and 90-day intervals, respectively. Conclusions: In this retrospective cohort of hospitalized diabetic patients at baseline, statin initiation at least 90-days in advance is associated with reduced indication of renal replacement therapy.

Source: Statin Exposure and Risk of Dialysis in Type 2 Diabetes: A Real-World Cohort Study